Drug Detail:Indocin sr (Indomethacin [ in-doe-meth-a-sin ])
Drug Class: Nonsteroidal anti-inflammatory drugs
Usual Adult Dose for Acute Gout
50 mg orally or rectally 3 times a day
Duration of therapy: Until gout attack has resolved
Comments:
- Relief of pain has been observed within 2 to 4 hours; tenderness and heat usually subside within 24 to 36 hours; swelling gradually disappears in 3 to 5 days.
- Extended release capsules are not recommended for the treatment of acute gouty arthritis.
Use: For the treatment of acute gouty arthritis.
Usual Adult Dose for Bursitis
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses
Suppository:
50 mg rectally up to 3 times a day
Extended Release:
75 mg orally once or twice a day
Comments:
- The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
- Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days
Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).
Usual Adult Dose for Tendonitis
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses
Suppository:
50 mg rectally up to 3 times a day
Extended Release:
75 mg orally once or twice a day
Comments:
- The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
- Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days
Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).
Usual Adult Dose for Pain
20 mg orally 3 times a day or 40 mg orally 2 to 3 times a day
Comment:
- The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
Use: For the treatment of mild to moderate acute pain
Usual Adult Dose for Rheumatoid Arthritis
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.
Usual Adult Dose for Ankylosing Spondylitis
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe ankylosing spondylitis.
Usual Adult Dose for Osteoarthritis
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe osteoarthritis.
Usual Pediatric Dose for Patent Ductus Arteriosus
Dosing depends on age of neonate at time of therapy; A course of therapy is defined as 3 IV doses given at 12 to 24 hour intervals.
Age at first dose: Less than 48 hours:
- First dose: 0.2 mg/kg IV
- Second dose: 0.1 mg/kg IV
- Third dose: 0.1 mg/kg IV
Age at first dose: 2 to 7 days:
- First dose: 0.2 mg/kg IV
- Second dose: 0.2 mg/kg IV
- Third dose: 0.2 mg/kg IV
Age at first dose: Over 7 days:
- First dose: 0.2 mg/kg IV
- Second dose: 0.25 mg/kg IV
- Third dose: 0.25 mg/kg IV
Comments:
- Monitor urinary output; if anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.
- If ductus arteriosus closes or has significantly reduced in size 48 hours or more after completion of the first course, no further doses are needed.
- If ductus arteriosus re-opens, a second course of 1 to 3 doses may be given.
- If neonate is unresponsive after 2 courses of therapy, surgery may be necessary.
Use: For the closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when 48 hours of usual medical management is ineffective; clear-cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present (e.g., respiratory distress, continuous murmur, hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray).
Usual Pediatric Dose for Rheumatoid Arthritis
2 to 14 years:
- Initial dose: 1 to 2 mg/kg/day orally in divided doses
- Maximum dose: 3 mg/kg/day or 150 to 200 mg/day, whichever is less; limited data supports a maximum of 4 mg/kg/day
Comments:
- Safety and efficacy have not been established in patients 14 years and younger; use should be limited to patients for whom toxicity or lack of efficacy with other drugs warrants the risk.
- As symptoms subside, the dose should be reduced or discontinued.
- Use in pediatric patients have been confined to the use of capsules.
Over 14 years:
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment:
- For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.
Usual Pediatric Dose for Ankylosing Spondylitis
Over 14 years:
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment:
- For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.
Usual Pediatric Dose for Osteoarthritis
Over 14 years:
Immediate-release capsules and suspension:
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository:
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Comment:
- For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.
Extended-release:
- Initial dose: 75 mg orally once a day
- Initial dose: 75 mg orally twice a day
Comments:
- Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
- During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
- Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.
Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.
Usual Pediatric Dose for Bursitis
Over 14 years:
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses
Suppository:
50 mg rectally up to 3 times a day
Extended Release:
75 mg orally once or twice a day
Comments:
- The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
- Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days
Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).
Usual Pediatric Dose for Tendonitis
Over 14 years:
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses
Suppository:
50 mg rectally up to 3 times a day
Extended Release:
75 mg orally once or twice a day
Comments:
- The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
- Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days
Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).
Renal Dose Adjustments
Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.
Neonates:
- Contraindicated in significant renal impairment.
- If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) occurs after a dose of IV therapy, no additional doses should be given until renal function returns to normal.
Liver Dose Adjustments
- Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
- If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.
- Pediatric: If the decision is made to use this drug in patients 2 years of age or older, close monitoring and periodic assessment of liver function is recommended; there have been reports of hepatotoxicity in pediatric patients with juvenile rheumatoid arthritis, including fatalities.
Dose Adjustments
Elderly:
- Careful dose selection is advised along with close monitoring of renal function.
Different dose strengths and formulations of oral indomethacin are not interchangeable; this difference should be taken into consideration when changing strengths or formulations.
Adverse events:
- If minor adverse effects develop during dose escalation, reduce dose rapidly to a tolerated dose and observe the patient closely; if severe adverse reactions develop, stop the drug.
- Once acute phase of disease is under control, an attempt to reduce daily dose should be made repeatedly until smallest effective dose is being given or drug is discontinued.
Precautions
US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
CONTRAINDICATIONS:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to the active drug or any of the ingredients
- History of asthma, urticaria, or other allergic-type reaction after taking aspirin or other NSAIDs; severe, sometimes fatal anaphylactic reactions to NSAIDs have been reported in such patients
- In the setting of coronary artery bypass graft (CABG) surgery
- History of proctitis or recent rectal bleeding (suppository)
CONTRAINDICATIONS for IV NEONATAL USE:
- Proven or suspected infection that is untreated
- Active bleeding, especially intracranial hemorrhage or GI bleeding
- Thrombocytopenia or coagulation defects
- Confirmed or suspected necrotizing enterocolitis
- Significant renal impairment
- Congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, or severe coarctation of aorta)
Oral and Rectal:
Safety and efficacy have not been established in patients 14 years of age and younger.
Tivorbex (R): Safety and efficacy have not been established in patients 17 years of age and younger.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
Take orally with food, milk, or antacid
- Oral Suspension: Shake well before use
- Rectal Suppositories: Wash hands before use; unwrap and insert rectally with pointed end first while laying on side with knees bent up; lie in place for at least 1 minute following insertion
- IV: Slow IV infusion over 20 to 30 minutes
Neonatal use:
- Optimal rate of IV injection has not been established, however, published literature suggests an IV infusion rate of 20 to 30 minutes
- Refer to manufacturer product information
- Must be prepared with preservative-free sterile Sodium Chloride or Water for injection only; benzyl alcohol as a preservative has been associated with toxicity in neonates
Storage requirements:
- Lyophilized vials: Protect from light; store in carton until ready for use
- Suppositories: Store at 2C to 8C (36F to 46F)
General:
- Prior to initiating treatment, the potential benefits and risks should be weighed against other treatment options.
- The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
- There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs). These events may occur at any time during treatment and risk increases with long term use; a history of, or risk factors for cardiovascular disease; and higher doses.
Monitoring:
- Neonates: Monitor renal function and serum electrolytes during therapy
- Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy
- Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding
- Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion
- Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- Patients should seek medical advice for signs and symptoms of cardiovascular events, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
- Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur, including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
- Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.
- Patients should be aware that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications.
- Advise patients not to engage in activities requiring mental alertness or motor coordination, including driving, until the effects of this drug are realized.
Frequently asked questions
- What is Ardosons called in the U.S?
- Why is my poop green? What does this mean?
- Can I take Tylenol while taking indomethacin and can these drugs be alternated every 3 hours?
